Reusable surgical implement

ABSTRACT

A reusable surgical implement is provided that is formed of a core positioned within an enclosure. The core is formed of a suitable flexible material to enable the implement, which can be any suitable device such as a reusable surgical trial implant, rod template or flex driver, among others, to be bent to conform to the desired shape for an actual implant to be placed in the location of the implement. The material forming the enclosure is also flexible to accommodate the flexing of the core, and is biologically inert to enable the implement to be sterilized after use for use in subsequent surgical procedures.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority as a continuation-in-part U.S.Non-Provisional patent application Ser. No. 14/317,337, filed on Jun.27, 2014, and from U.S. Provisional Patent Application Ser. No.61/840,299, filed on Jun. 27, 2013, the entirety of which are eachhereby expressly incorporated by reference herein.

FIELD OF THE DISCLOSURE

The present invention relates generally to implements utilized insurgical procedures and more specifically to reusable implementsutilized in surgical procedures.

BACKGROUND OF THE DISCLOSURE

There are many types of implements that are used in surgical procedures.The implements, such as implants, provide a physician with the abilityto stabilize portions of the body that are being repaired in a surgicalor medical procedure.

Oftentimes, the physician needs to determine the proper location andorientation for the implant prior to actually positioning and securingthe implant within the body. To do so, a trial or template implant isutilized. This trial or template implant can be formed of aluminum ortitanium with an anodized exterior coating (e.g., Ti06AL-4V), and isformed with a configuration similar to the form of the actual implant tobe secured within the body. In use, the trial or template implant isplaced within the body and manipulated by the physician to determine theproper location for the actual implant. Once determined, the locationcan be marked and the actual implant affixed within the body using knownprocedures.

However, with these prior art trial or template implants, the nature ofthe aluminum or anodized titanium used to form them requires that thetrial or template implant be used only once and then discarded. Thereason for this is that the anodized coating, which is necessary fortrial or template implants formed of aluminum or titanium, can becomebrittle or otherwise damaged upon sterilization after an initial use.Thus, the coating can flake off during subsequent uses and consequentlyendanger the patient.

In addition, other implements that are designed for use in varioussurgical procedures are formed of rigid materials. These constructionsmake it difficult for medical practitioners to use devices of this typein confined spaces, and can result in the individual having to use theimplement at an awkward angle. Also, in other implements of this typeformed with flexible structures, the implements have exposed springs orcoils which could trap debris, making the element hard to clean forsubsequent uses.

To provide added functionality to these implements, some flexibleimplements have tubing sleeves which cover the flexible coils orsprings. However, these tubes do not closely conform to the shape of thecoils and/or springs, providing a space between the flexible element andthe tube within which debris can be trapped.

Thus, it is desirable to develop implements for surgical procedures,such as trial or template implants, that is formed of a material that isflexible in nature and that can be sterilized and reused in multipleprocedures.

SUMMARY OF THE DISCLOSURE

Briefly described, one aspect of the present disclosure provides areusable surgical implement, such as a trial or template implant, a rodtemplate or flex driver, among others, formed of a substantially rigid,but flexible core material that is enclosed within an inert and flexiblematerial that is capable of being sterilized after use to enable theimplement to be reused. In the case of a trial implant, the inertmaterial is molded over the core material to conform to the shape of theactual implant to provide the appropriate representation of the actualimplant to be placed within the body of the patient. Once used, thetrial implant can be removed and placed with the actual implant, withthe trial implant being subsequently sterilized, such as in anautoclave, for additional uses.

According to another aspect of the present disclosure, the inertmaterial is flexible to accommodate the flexibility of the core materialwhile maintaining the core enclosed within the inert material. Thus, theimplement can be bent in order to accurately represent the properlocation and configuration or use of the actual implement within thebody. In addition, the material allows for implements having other uses,such as flex drivers, to be shaped and/or oriented as necessary with theinert material maintaining conformance with the flexible core materialfor a physician to accurately locate the implement and drive a fastenerused in the procedure when presented with hard to reach areas or anglesduring the procedure. After use, the inert material enables the flexdriver to be cleaned and/or sterilized for further uses without damagingthe core material, components and mechanism(s).

According to still another aspect of the present disclosure, the inertmaterial molded around the core material can be formed with structuresor components that facilitate the engagement of the inert material witha second inert material formed around the core and the first inertmaterial. The engagement of the first inert material with the secondinert material provides an enclosure around the core material thateffectively prevents dirt, dust or other debris from contacting the corematerial, thereby enabling repeated sterilization and usage of the corematerial and inert materials as a template, rod template, flex driver orother surgical device.

Numerous other aspects, features, and advantages of the presentinvention will be made apparent from the following detailed descriptiontogether with the drawing figures.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the best mode currently contemplated ofpracticing the present invention.

In the drawings:

FIG. 1 is an isometric view of a one exemplary embodiment of a reusablesurgical implement constructed according to the present disclosure;

FIG. 2 is a an exploded view of the trial implant of FIG. 1;

FIG. 3 is a side elevation view of the trial implant of FIG. 1;

FIG. 4 is an exploded view of the trial implant of FIG. 3;

FIG. 5 is a top plan view of the trial implant of FIG. 1;

FIG. 6 is a bottom plan view of the trial implant of FIG. 1;

FIG. 7 is an end elevation view of the trial implant of FIG. 1;

FIG. 8 is an exploded view of the trial implant of FIG. 7;

FIG. 9 is an isometric view of another exemplary embodiment of areusable surgical implement constructed according to the presentdisclosure;

FIG. 10 is a side elevation view of the implement of FIG. 9;

FIG. 11 is a cross-sectional view along line 11-11 of FIG. 10;

FIG. 12 is an isometric view of the implement of FIG. 9 after a firstmolding step;

FIG. 13 is a side elevation view of the implement of FIG. 12;

FIG. 14 is a cross-sectional view along line 14-14 of FIG. 13;

FIG. 15 is an isometric view of the implement of FIG. 9 after a secondmolding step;

FIG. 16 is a side elevation view of the implement of FIG. 15;

FIG. 17 is a cross-sectional view along line 17-17 of FIG. 16;

FIG. 18 is an isometric view of still another exemplary embodiment of animplement constructed according to the present disclosure;

FIG. 19 is a side elevation view of the implement of FIG. 18;

FIG. 20 is an isometric view of the implement of FIG. 18 after a firstmolding step;

FIG. 21 is a side elevation view of the implement of FIG. 20;

FIG. 22 is an isometric view of the implement of FIG. 18 after a secondmolding step;

FIG. 23 is a side elevation view of the implement of FIG. 22;

FIG. 24 is an isometric view of a further exemplary embodiment after afirst molding step;

FIG. 25 is a side plan view of the embodiment of FIG. 24;

FIG. 26 is a cross-sectional view along line 26-26 of FIG. 25;

FIG. 27 is an isometric view of the embodiment of FIG. 24 after a secondmolding step;

FIG. 28 is a top plan view of the embodiment of FIG. 27;

FIG. 29 is a cross-sectional view along line 29-29 of FIG. 28;

FIG. 30 is an isometric view of still a further exemplary embodimentafter a first molding step;

FIG. 31 is a side plan view of the embodiment of FIG. 30;

FIG. 32 is a cross-sectional view along line 32-32 of FIG. 31;

FIG. 33 is an isometric view of the embodiment of FIG. 30 after a secondmolding step;

FIG. 34 is a top plan view of the embodiment of FIG. 33;

FIG. 35 is a cross-sectional view along line 35-35 of FIG. 34;

FIG. 36 is an isometric view of still another exemplary embodiment aftera first molding step;

FIG. 37 is a side plan view of the embodiment of FIG. 36;

FIG. 38 is a cross-sectional view along line 38-38 of FIG. 37;

FIG. 39 is an isometric view of the embodiment of FIG. 36 after a secondmolding step;

FIG. 40 is a top plan view of the embodiment of FIG. 39;

FIG. 41 is a cross-sectional view along line 41-41 of FIG. 40;

FIG. 42 is an isometric view of a further exemplary embodiment after afirst molding step;

FIG. 43 is a side plan view of the embodiment of FIG. 42;

FIG. 44 is a cross-sectional view along line 44-44 of FIG. 43;

FIG. 45 is an isometric view of the embodiment of FIG. 42 after a secondmolding step;

FIG. 46 is a top plan view of the embodiment of FIG. 45;

FIG. 47 is a cross-sectional view along line 47-47 of FIG. 46;

FIG. 48 is an isometric view of still another exemplary embodiment aftera first molding step;

FIG. 49 is a side plan view of the embodiment of FIG. 48;

FIG. 50 is a cross-sectional view along line 50-50 of FIG. 49;

FIG. 51 is an isometric view of the embodiment of FIG. 48 after a secondmolding step;

FIG. 52 is a top plan view of the embodiment of FIG. 51;

FIG. 53 is a cross-sectional view along line 53-53 of FIG. 52.

DETAILED DESCRIPTION OF THE DRAWINGS

Referring now in detail to the drawing figures, wherein like referencenumerals represent like parts throughout the several views, oneexemplary embodiment of a reusable surgical implement, formed as a trialor template implant constructed according to the present disclosure isillustrated generally at 10 in FIG. 1. As best shown in FIGS. 1-8, theimplant 10 is formed of a central core 12 and an enclosure 14 disposedaround the core 12 formed of an upper portion 16 and a lower portion 18.In the illustrated embodiment, the implant 10 is formed with apre-curved shape, though other configurations for the implant 10 as alsocontemplated as being within the scope of the disclosure of the presentinvention.

Referring now to FIGS. 2, 4 and 8, though any suitable shape for thecore 12 can be utilized, in the illustrated embodiment the core 12 isformed with a generally rectangular configuration with a first end 20and a second end 22 joined by opposed sides 24. In the illustratedembodiment the core 12 is also formed to be generally rectangular incross-section with a pair of generally flat opposed surfaces 26 joiningthe ends 20, 22 and the sides 24, though any suitable cross-sectionalshape can be utilized to impart the desired amount of flexibility to thecore 12. The core 12 is shaped in any suitable machine and/or process toprovide the desired shape for the core 12, which may include aperturesor other features therein, as desired.

The material forming the core 12 is selected to be a generally rigid,but flexible material that can be altered in shape by applying aphysical force to the core 12. Once the force is removed, the core 12remains in the shape to which it was altered by the applied force. Inone embodiment of the core 12, the core 12 is formed of a shape memorymaterial, such as a shape memory metal alloy, including the materialsmarketed under the trade name Nitinol® by Nitinol Devices & Components,Inc. of Fremont, Calif.

The enclosure 14 is disposed around the core 12 and each portion 16 and18 of the enclosure 14 is formed of a biologically inert and flexiblematerial that can conform to the shape of the core 12 in anyconfiguration for the core 12. In one embodiment, the material formingthe portions 16 and 18 of the enclosure 14 is a silicone, such as asilicone rubber, including a high consistency rubber (HCR) or liquidsilicone rubber (LSR).

The portions 16 and 18 of the enclosure 14 are formed with features 26that are identical or at least similar to those of the actual implant(not shown) to be secured within the body of the patient, to provide anaccurate representation of the proper location of the actual implant inthe body. The features 26 can include apertures 28 and notches 30, amongothers. The apertures 28 can extend completely through the respectiveportions 16 and 18 without intersecting the core 12, thereby preservingthe integrity of the enclosure 14 around the core 12. Further, the shapeof the portions 16 and 18 forming the enclosure 14 can be shaped asdesired to approximate the shape of the actual implant. Also, the shapeof the portions 16 and 18 can be selected independently of the shape ofthe core 12, or to conform to the shape of the core 12, as desired.

In one embodiment, the trial implant 10 is formed by initially formingthe core 12 of the desired material in any suitable manner, such as byextruding or molding the material into the desired shape for the core12. The core 12 is then placed within a suitable mold to enable thematerial selected form either the upper portion 16 or the lower portion18 to be introduced into the mold containing the core 12 and form aportion of the enclosure 14 on or over the core 12 that contains thedesired features 26. Any suitable molding process can be utilized toform the upper portion 16 or lower portion 18 around the core 12.

Subsequently, the core 12 and the portion 16 or 18 molded onto or overthe core 12 are removed or transferred from the first mold and placedwithin a separate or second mold used to form the other of the upperportion 16 or the lower portion 18 on or over the core 12 in connectionwith the first portion 16 or 18 and with the desired features 26. Thematerial selected to form the other portion 16 or 18 can be selected tobe the same or different than the material used to form the firstportion 16 or 18, to provide the desired attributes to the enclosure 14and the implant 10, so long as the materials forming the upper portion16 and lower portion 18 are capable of mating, co-mingling or otherwisejoining to one another in the molding process to form the enclosure 14around the core 12. Additionally, suitable materials can be applied toone or both of the portions 16 and/or 18 to properly affix the portions16 and 18 to one another, either during molding of the portions 16 and18 to one another, or when affixing pre-molded portions 16 and 18 to oneanother around the core 12.

In alternative embodiments, the portions 16 and 18 can be formedsubsequently or simultaneously within a single mold in any suitablemolding process.

In use, the implant 10 in a sterile condition is placed within the bodyof a patient and bent, such as by hand, to conform the implant 10 to theshape desired for the actual implant within the body. In this positionand shape, the location for suitable securing members, such as screws,are marked using the positions of the various features 26 formed in theimplant 10. The implant 10 can then be removed and replaced by theactual implant which is affixed within the body of the patient using themarked locations for the securing members.

Once removed from the body, the implant 10 can be cleaned and sterilizedfor additional uses. When sterilized, the heat used to sterilize theimplant 10 can also activate the material forming the core 12 to returnthe implant 10 to its initial pre-bent configuration or shape, thusmaking the implant 10 ready for use once the sterilization process hasbeen completed.

As best shown in FIGS. 9-17, a second exemplary embodiment of theimplement is formed as a rod template 100 having a central core 12′ andan enclosure 14′ disposed around the core 12′ formed of a firstcomponent or portion(s) 16′ and a second component or portion(s) 18′. Inthe illustrated embodiment, the rod template 100 is formed similarly tothe implant 10, and can be generally straight, though otherconfigurations for the rod template 100 are also contemplated as beingwithin the scope of the disclosure of the present invention.

Though any suitable shape for the core 12′ can be utilized, in theillustrated embodiment the core 12′ is formed with a generally flatrectangular or cylindrical cross-sectional shape with a first end 20′and a second end 22′ joined by opposed sides 24′, though any suitablecross-sectional shape can be utilized to impart the desired amount offlexibility to the core 12′. The core 12′ is shaped in any suitablemachine and/or process to provide the desired shape for the core 12′,which may include apertures or other features therein, as desired.

The material forming the core 12′ is selected to be a generally rigid,but flexible material that can be altered in shape by applying aphysical force to the core 12′. Once the force is removed, the core 12′remains in the shape to which it was altered by the applied force. Inone embodiment of the core 12′, the core 12′ is formed of a shape memorymaterial, such as a shape memory metal alloy, including the materialsmarketed under the trade name Nitinol® by Nitinol Devices & Components,Inc. of Fremont, Calif.

The enclosure 14′ is disposed around the core 12′ and each portion 16′and 18′ of the enclosure 14′ is formed of a biologically inert andflexible material that can conform to the shape of the core 12′ in anyconfiguration for the core 12′. In one embodiment, the material formingthe portions 16′ and 18′ of the enclosure 14′ is a silicone, such as asilicone rubber, including a high consistency rubber (HCR) or a liquidsilicone rubber (LSR).

The portions 16′ and 18′ of the enclosure 14′ are formed with anyfeatures (not shown) desired to enhance the utility of the implement 100when utilized within the body of the patient. The features can includeapertures (not shown) and notches (not shown), among others. Theapertures can extend completely through the respective portions 16′ and18′ without intersecting the core 12′, thereby preserving the integrityof the enclosure 14′ around the core 12′. Further, the shape of theportions 16′ and 18′ forming the enclosure 14′ can be shaped as desired.Also, the shape of the portions 16′ and 18′ can be selectedindependently of the shape of the core 12′, or to conform to the shapeof the core 12′, as desired.

In the illustrated embodiment, the implement 100 is formed by initiallyforming the core 12′ of the desired material in any suitable manner,such as by extruding or molding the material into the desired shape forthe core 12′, as shown in FIGS. 9-11. The core 12′ is then placed withina suitable mold to enable the material selected to form the firstportion 16′ to be introduced into the mold containing the core 12′ andform a portion of the enclosure 14′ on or over the core 12′ thatcontains the desired features. Any suitable molding process can beutilized to form the first portion 16′ around the core 12′, such asthose shown in commonly owned U.S. Pat. No. 8,641,955 and its relatedapplications, each of which are expressly incorporated by referenceherein in their entirety. In the illustrated embodiment best shown inFIGS. 12-14, the first portion 16′ constitutes a number of spacedsections 102 disposed along the length of the core 12′.

Subsequently, the core 12′ and the first portion 16′ molded onto or overthe core 12′ are removed or transferred from the first mold and placedwithin a separate or second mold used to form the other of the secondportion 18′ on or over the core 12′ in connection with the first portion16′ and with the desired features. The material selected to form thesecond portion 18′ can be selected to be the same or different in one ormore respects or attributes than the material used to form the firstportion 16′, in order to provide the desired attributes to the enclosure14′ and the implement 100, so long as the materials forming the firstportion 16′ and second portion 18′ are capable of mating, co-mingling orotherwise joining to one another in the molding process used to form theenclosure 14′ around the core 12′, which can be the same or differentthat the process used to form the first section 16′. Additionally,suitable materials can be applied to one or both of the portions 16′and/or 18′ to properly affix the portions 16′ and 18′ to one another,either during molding of the portions 16′ and 18′ to one another, orwhen affixing pre-molded portions 16′ and 18′ to one another around thecore 12′.

In alternative embodiments, the portions 16′ and 18′ can be formedsubsequently or simultaneously within a single mold in any suitablemolding process. In the illustrated embodiment, the second portion 18′includes a number of spaced sections 104 disposed along the length ofthe core 12′ alternating in a sequential manner between and joining thesections 102 to form the enclosure 14′. In this embodiment, as shown inFIGS. 15-17, the sections 102 and 104 form a seamless enclosure 14′around the core 12′ complete with end caps 106 disposed over each end20,22 of the core 12, which can be molded with either of the sections102 or 104, or separately therefrom. The seamless enclosure 14′ movesand/or flexes with the core 12′ to retain the core 12′ encased withinthe enclosure 14′, such that the sterilization of the implement 100 doesnot contact the core 12′.

A third embodiment of the implement 200 shown in FIGS. 18-23 illustratesthe implement 200 as a flex driver. The implement 200 includes aflexible core 212, such as a spring or coil, with a pair of opposed ends220 and 222 that, for example, is used to drive a fastener in a surgicalprocedure and may optionally include a mechanism suitable to assist inthe driving of the fastener, such as a ratcheting or torque-limitingmechanism, among others. The ends 220 and 222 define a central section224 therebetween, as best shown in FIGS. 18-21. In the embodiment shownin FIGS. 20 and 21, the first portion 216, which can be formed similarlyto the first portion 16′ in the prior embodiment, is molded onto thecore 212 in a first mold in a first molding step over at leastapproximately one half of the central section 224 in a suitable process,such as those cited as examples for the molding of the first portion 16′in the prior embodiment. In this process, however, the ends 220 and 222can function as stops for the flow of the material forming the firstportion 216 at each end 220 and 222.

Subsequently, the core 212 can be removed from the first mold forpositioning in a second mold, or simply rotated within the first mold toexpose the uncovered portion 226 of the central section 224 within thesecond mold. One properly positioned, the second portion 218 can beformed over the uncovered section 226 to form the enclosure 214 over thecentral section 224 with the first portion 216 and without end caps,leaving the ends 220,222 exposed. In this configuration, the core 212can be flexed as desired to properly orient the ends 220,222 to utilizethe implement 200, but the enclosure 214 remains in close conformancewith the core 212 to prevent debris from becoming positioned between theenclosure 214 and the core 212, and to limit the exposure of the core212 to the sterilization environment when being sterilized forsubsequent uses.

In alternative embodiments for either embodiment of the implement 100,200, the process for molding the first portion 16′, 216 and/or secondportion 18′, 218 can be performed in any number of separate moldingsteps in order to form the enclosure 14′, 214 on the core 12′,212 withthe desired appearance, attributes or other characteristics with anydesired number and/or types of different materials forming the portions16′,216 and/or 18′,218.

Additional molding processes are also available for forming theenclosure 14, 14′ or 214 around the core 12, 12′ or 212. Examples ofsome of these types of molding processes are disclosed in U.S. patentapplication Ser. No. 14/168,600, which is expressly incorporated hereinby reference.

Looking now at FIGS. 24-29, in an alternative exemplary embodiment, theimplement 300 includes a core 312, which is illustrated as an elongaterod having a circular cross-section but can have any desiredcross-sectional shape, has a first portion 316 of a flexible and inertmaterial molded or otherwise formed around the core 312 in a firstmolding or forming step. As best shown in FIGS. 24-26, after the firstmolding step, the first portion 316 formed in the step includes a pairof outer sections 318 spaced inwardly from opposed ends of the core 312that are joined by an inner section 320. The inner section 320 isintegrally joined to one end of each outer section 318 in order to forma continuous molded piece around the core 312, which can optionallyencircle the core 312 or leave certain portions of the core 312uncovered. For example, in the illustrated exemplary embodiment of FIG.24-30, the outer sections 318 do not extend completely around the core312 and have a semi-circular cross-section. Further, the inner section320 also does not extend completely around the core 312 and has asemi-circular cross-section oriented 180° from the outer sections 318 tofacilitate the joining of the inner section 320 to the outer sections318. The inner section 320 also has a thickness or radius that is lessthan that of the outer sections 318, such that the inner section 318covers the portion of the core 312 where the inner section is located,but does not extend outwardly from the core 312 the same distance as theouter sections 318.

In FIGS. 27-29, in another exemplary embodiment of the implement 300after a second molding or forming step a second portion 322 formed of aflexible and inert material is molded or formed around and over thefirst portion 316. The second portion 322 forms an enclosure 324 aroundthe core 312 in conjunction with the first portion 316. The secondportion 322 is formed to be complementary to the outer sections 318 ofthe first portion 316 such that the enclosure 324 has an exteriorsurface 326 formed of the outer surfaces of the outer sections 318 ofthe first portion 316 and the second portion 322. In the illustratedexemplary embodiment of FIGS. 27-29, the second portion 322 completelycovers the inner section 320 of the first portion 316 and forms acylindrical enclosure 324 around the exposed ends 321 of the core 312and inner section 320, with a complementary radius to the outer sections318, such that the outer sections 318 form exposed panels 327 on theenclosure 324 within the second portion 322. When formed, the materialforming the second portion 322 bonds and/or engages the first portion316 in a manner to form a seamless enclosure 324 around the core 312.

Referring now to FIGS. 30-35, in another exemplary embodiment of theimplement 300 the first portion 316 is formed around the core 312 with anumber of inner sections 320 joining adjacent outer sections 318, withan outer section(s) 318 that encloses a portion of an end 321 of thecore 312, as best shown in FIGS. 30-32. The outer section(s) 318 formedover the end(s) 321 includes a cap 328 that extends past the end 321 andterminates in an end surface 330 that can be flat. When the secondportion 322 is formed or molded around the core 312 and the firstportion 316 to form the enclosure 324, the second portion 322 abuts thecap 328 formed by the outer section 318 and terminates in a flat surface332 that is coplanar with the flat surface 330 on the cap 328.

Looking now at FIGS. 36-41, in another exemplary illustrated embodimentof the implement 300, the first portion 316 is formed around the core312 with a number of inner sections 320 joining adjacent outer sections318, and with an outer section(s) 318 that encloses an end 321 of thecore 312, as best shown in FIGS. 36-38. The second portion 322 is formedaround the core 312 and the first portion 316 as in previousembodiments, but the second portion 322 abuts the outer section 318enclosing the end 321 of the core 312, such that the outer section 318around the end 321 forms a part of the exterior of the enclosure 324around the entire perimeter of the enclosure 324 adjacent the end 321,as best shown in FIGS. 39-41.

In another exemplary embodiment of the implement 300 illustrated inFIGS. 42-47, the outer sections 318 of the first portion 316 are eachformed with a locating feature that in the illustrated exemplaryembodiment takes the form of a recess 340 at each end of the outersection 318. The recess 340 extends along at least a part of anoptionally the entire perimeter of the end of the outer section 318 andforms a sealing and locating feature for the placement of the firstportion 316/outer sections 318 within the mold for forming the secondportion 322 around the core 312 and first portion 316. Thus, the recess340 effectively separates the outer sections 318 from the second portion322 when formed around the core 312, with the recess 340 remainingbetween the outer sections 318 and the second portion 322 when formingthe enclosure 324 around the core 312, as best shown in FIGS. 45-47.Further, recess 340 can additionally be located in other areas of thefirst portion 316, such as along the edges 342 of the outer sections 318extending parallel to the long axis of the core 312.

In still another exemplary embodiment of the implement 300 illustratedin FIGS. 48-53, the core 312 can be formed of multiple rods, cores ormembers 350 that are at least partially enclosed within the firstportion 316. The members 350 are oriented relative to one another, andoptionally parallel to one another in the illustrated exemplaryembodiment, and are spaced from one another as they extend between theouter sections 318 and the inner section 320. The cross-sectional shapeof the outer sections 318 and inner section 320 of the first portion 316and the second portion 322 can vary as necessary to accommodate themembers 350 to form an enclosure around the members 350, but in theillustrated exemplary embodiment, the first portion 316 and secondportion 322 form a rectangular cross-sectional enclosure 324 around themembers 350.

Further, in alternative embodiments, any of the features and/orconstructions of the previously described embodiments can be combinedwith one another to form additional embodiments of the invention.

Various other embodiments of the present disclosure are contemplated asbeing within the scope of the filed claims particularly pointing out anddistinctly claiming the subject matter regarded as the invention.

The invention claimed is:
 1. A reusable surgical implement comprising:a) a core formed of a rod of a shape memory material; and b) anenclosure formed around the core, wherein the enclosure includes a firstportion having an inner section and a number of outer sections joined bythe inner section; wherein the inner section and the outer sections areoriented at an angle of 180° with respect to one another, such that theinner section and the outer sections enclose portions and do not encloseportions of the core at an angle of 180° with respect to one another,and wherein the enclosure further comprises a second portion thatcompletely covers the inner section and abuts the outer sections.
 2. Thereusable surgical implement of claim 1, wherein the inner section andthe outer sections have different thicknesses.
 3. The reusable surgicalimplement of claim 1, wherein the inner section does not completelyenclose the core.
 4. The reusable surgical implement of claim 1, whereinthe outer sections do not completely enclose the core.
 5. The reusablesurgical implement of claim 1, wherein the outer sections and the secondportion form a seamless exterior surface for the enclosure.